Electronic Records Electronic Signatures GxP Training Course Overview

For Pharmaceutical and Medical Device Manufacturing, Zener Engineering Services Ltd (ZES) have worked closely with FDA, MHRA and EMA inspectors to ensure GxP Facilities, IT Infrastructure, Process Equipment and Computer Systems have reached the required standard for their first inspection and inspections beyond.

Whatever your Electronic Records Electronic Signatures concerns, ZES are experts in helping Clients achieve their goals and compliance success.

In this course employees will gain a comprehensive understanding of the regulations and, by completing the course, ensure they are equipped with the skills and knowledge needed to achieve and maintain compliance in their organisations.

Understand the Regulatory Framework:

• Students will understand the regulatory framework and purpose of 21 CFR Part 11, including its history, scope, and significance in ensuring the integrity and security of Electronic Records and Electronic Signatures.
• Students will be able to identify and explain the key requirements and components of 21 CFR Part 11, including controls for closed and open systems, audit trails, and system validation.
  

Understand the requirements for ERES Validation:

• Students will learn the principles and practices of system validation to ensure that electronic systems used for managing records and signatures comply with 21 CFR Part 11 requirements.
• Students will understand the essential criteria for electronic records to be adequately maintained, including how to ensure their accuracy, integrity, and availability throughout their lifecycle.
• Students will be able to describe the requirements for Electronic Signatures under 21 CFR Part 11, including how to establish and maintain secure, legally binding signatures.
• Students will learn how to implement and maintain Audit Trails that comply with 21 CFR Part 11, ensuring that all changes to Electronic Records are tracked and traceable.
• Students will understand the security measures required to protect Electronic Records and Signatures from unauthorised access or alterations, including user authentication and access controls.

Understand the requirements for ERES Management:

• Students will learn how to develop strategies for achieving and maintaining compliance with 21 CFR Part 11, including conducting risk assessments and implementing appropriate controls.
• Students will learn how to effectively prepare for Regulatory Inspections and Audits by understanding what Regulatory Inspectors look for regarding 21 CFR Part 11 compliance and how to demonstrate adherence to the regulations.
• Students will learn best practices for documentation to ensure that electronic records meet Part 11 requirements, including proper documentation of ERES system validations and user training.

• Understand the legal requirements and regulations related to electronic signatures and records.
• Ensure personal practices align with industry standards and legal frameworks.

• Gain insights into best practices for ensuring the security and integrity of electronic documents.
• Learn about encryption, authentication, and other security measures.

• Develop proficiency in using electronic signature and record-keeping tools.
• Stay current with technology trends and advancements in digital documentation.

• Improve job prospects by adding a valuable skill to their resume or c.v.
• Position oneself as an specialist in electronic documentation within their field.

• Contribute to sustainability by reducing paper usage and promoting digital alternatives.

• Ensure the company adheres to national and international laws and standards regarding electronic records.
• Mitigate risks of non-compliance with regulatory requirements.

• Cut down on expenses related to paper, printing, storage, and mailing.
• Reduce administrative costs by minimizing errors and rework.

• Implement robust security measures to protect sensitive information.
• Reduce risks associated with document fraud and data breaches.

• Stay ahead of competitors by adopting innovative digital solutions.
• Position the company as a forward-thinking, technology-savvy organization.

• Facilitate remote work and collaboration by enabling easy access to electronic records.
• Adapt to changing business needs with scalable digital documentation processes.